LogoFDA 510(k) Search
K Number
K024185
Device Name
BIODHOC
Manufacturer
FUTURE MEDICAL SYSTEMS, SA
Date Cleared
2004-01-15

(392 days)

Product Code
HTY
Regulation Number
888.3040
Type
Traditional
Panel
OR
Reference & Predicate Devices
K991009,K023963
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The BIODHOC is an implant used for rotator cuff repair in shoulder surgery.

Device Description

The BIODHOC is an implant used for rotator cuff repair in shoulder surgery. The BIODHOC is made of poly DL- lactic acid (PLLA) a bio absorbable polymer.

AI/ML Overview

This 510(k) submission does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria for software or an AI/ML device.

The provided document is a 510(k) summary for a "Soft Tissue Fixator" named BIODHOC, which is an implant used for rotator cuff repair. It describes a physical medical device, not a software or AI/ML product. The content focuses on:

  • Manufacturer and contact information.
  • Device name, common name, classification, and predicate devices.
  • Intended use and description of the physical implant (made of poly DL-lactic acid).
  • A statement of substantial equivalence to predicate physical devices.
  • The FDA's letter granting 510(k) clearance, confirming substantial equivalence for a physical device.
  • Indications for use for the physical implant.

Therefore, I cannot extract the requested information (performance characteristics, sample sizes, ground truth details, expert qualifications, MRMC studies, standalone performance, training set details) because these concepts are specific to software, AI, or diagnostic imaging devices, and are not present in this submission for a surgical implant.

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.